Ofev (nintedanib) is a brand-name prescription medication. The Food and Drug Administration (FDA) has approved it to treat the following lung conditions in certain people:
- idiopathic pulmonary fibrosis (lung scarring due to an unknown cause)
- worsening interstitial lung disease (ILD)
- ILD related to systemic sclerosis, also known as scleroderma
Here are some fast facts about Ofev:
- Active ingredient: nintedanib
- Drug class: kinase inhibitor
- Drug form: oral capsule
If Ofev works to manage your condition, your doctor will likely recommend that you take it long term.
As with other drugs, Ofev can cause side effects. Read on to learn about potential common, mild, and serious side effects. You can also learn about managing Ofev side effects. For a general overview of Ofev, including details about its uses, see this article.
Ofev can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Ofev in clinical trials:
- abdominal pain
- vomiting
- decreased appetite
- headache
- mild diarrhea*
* For more information about this side effect, see “Side effect specifics” below.
Mild side effects can occur with Ofev use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Ofev’s prescribing information.
Mild side effects that have been reported with Ofev include:
- hair loss
- abdominal pain
- vomiting
- decreased appetite, which may result in weight loss
- headache
- nausea
- back pain
- fatigue*
- mild diarrhea*
- mild allergic reaction*
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Ofev and want to tell the FDA about it, visit MedWatch.
* For more information about this side effect, see “Side effect specifics” below.
In most cases, Ofev can cause mild side effects. However, it’s also possible for Ofev to cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Ofev’s prescribing information.
If you develop serious side effects while taking Ofev, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported and their symptoms include:
- Severe nausea or vomiting. Symptoms may include:
- decreased appetite
- confusion
- Increased levels of liver enzymes, which may indicate liver damage. Symptoms can include:
- abdominal pain
- nausea or vomiting
- inability to keep food down
- Blood clots, which can lead to serious problems such as heart attack or stroke. Symptoms may include:
- chest pain
- trouble breathing
- headache
- dizziness
- numbness on one side of the body
- Bleeding. Symptoms may include:
- bruising easier than usual
- unusual bleeding
- an injury or wound that is not healing
- Protein in your urine, which may indicate kidney problems. Symptoms may include:
- swelling in your hands, arms, legs, or feet
- foamy urine
- weight gain
- Severe diarrhea.*
- High blood pressure.*
- Gastrointestinal perforation (tears in the stomach or intestines).*
- Severe allergic reaction.*†
* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after taking Ofev. However, it’s not clear whether this side effect occurred in clinical trials.
Learn more about some of the side effects that Ofev may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Ofev.
Fatigue
Some people may experience fatigue (low energy) from taking Ofev. However, fatigue was not one of the most common side effects that people taking Ofev reported.
If you experience fatigue from Ofev, you may feel more tired than usual. Or you may feel as if you don’t have the energy to do your usual activities.
What you can do
If Ofev does make you tired or fatigued, tell your doctor. In rare cases, fatigue may be related to other side effects of Ofev, such as liver problems. (To learn more, see the “Serious side effects of Ofev” section above.)
Your doctor can help determine if your fatigue is a side effect of Ofev. They’ll also recommend the best ways to treat it.
Diarrhea
It’s possible to have diarrhea during treatment with Ofev. In fact, diarrhea was one of the most common side effects that people taking Ofev reported in clinical trials. It usually occurs in the first 3 months after you start taking the drug. And it’s possible that this side effect may go away or improve over time.
In most cases, diarrhea may be mild from Ofev treatment. However, it’s also possible to develop severe diarrhea while taking the drug. This can lead to dehydration, which can be very serious.
What you can do
If you develop diarrhea from taking Ofev, tell your doctor. They can recommend ways to stay hydrated, such as drinking lots of water or eating hydrating foods. They can also recommend other medications to decrease your diarrhea, such as loperamide (Imodium).
In some cases, your doctor may recommend that you take a lower dose of Ofev to decrease this side effect. However, in more severe cases, they may recommend pausing your Ofev treatment. Or they’ll have you stop taking the drug completely. If so, they’ll likely recommend a different medication for your lung condition.
Gastrointestinal perforation (tears in the stomach or intestines)
It’s possible to develop a gastrointestinal perforation (tear in the stomach or intestines) from Ofev treatment. This side effect was rarely reported in people taking Ofev in clinical trials.
Symptoms of this side effect may include abdominal pain or swelling.
You may have an increased risk of tears in your stomach or intestines if you:
- have had a recent surgery in your abdomen*
- have diverticular disease (inflammation of the pouches in your colon)*
- are taking other medications, such as:
- nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen (Advil)
- corticosteroids, including prednisone (Rayos)
What you can do
Your doctor will monitor you for symptoms of tears in your stomach or intestines during your Ofev treatment. If you develop any symptoms, be sure to tell your doctor right away. They’ll likely recommend that you stop Ofev treatment. Also, they’ll recommend ways to treat your stomach or intestinal tear.
* To learn more, see the “Ofev precautions” section below.
High blood pressure
It’s possible for Ofev to cause high blood pressure during treatment. This was a common side effect reported by people taking Ofev in clinical trials.
Typically, high blood pressure does not cause noticeable symptoms. However, very high blood pressure may cause the following symptoms:
- excessive sweating
- heart palpitations
- shortness of breath
- lightheadedness
- severe headache
- vision problems, such as blurry vision
- confusion
In rare cases, very high blood pressure can be serious or even life threatening. It can also lead to organ damage.
What you can do
If you have symptoms of very high blood pressure, you should immediately call 911 or your local emergency number or seek urgent medical care.
Your doctor may recommend that you monitor your blood pressure throughout your Ofev treatment. This is to be sure that it does not get too high.
Also, if you’ve ever had high blood pressure, tell your doctor before starting Ofev treatment. In this case, they may recommend more frequent monitoring of your blood pressure when you’re taking Ofev. Or they may recommend a different treatment option for you.
If you develop high blood pressure from Ofev treatment, talk with your doctor. They may recommend that you take blood pressure medications to manage your blood pressure levels.
Allergic reaction
As with most drugs, Ofev can cause an allergic reaction in some people. However, it’s not clear whether this side effect occurred in clinical trials of the drug.
Symptoms can be mild or serious and can include:
- skin rash
- itching
- flushing
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Ofev. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Ofev may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Do the 100-mg and 150-mg strengths of Ofev cause different side effects?
No, these strengths aren’t expected to cause different side effects. However, your risk of side effects may increase if you take a higher dosage. This is because when you have more of a drug in your body, your risk of side effects can increase.
So, if you take the 150-milligram (mg) capsules of Ofev, it’s possible to have an increased risk of side effects than if you took the 100-mg capsules. The severity of these side effects may also be greater.
To learn more about your risk of side effects with Ofev, talk with your doctor.
Are the side effects of Ofev and Esbriet the same?
No. The side effects of Ofev and Esbriet are similar, but they are not the same. Both Ofev and Esbriet are medications that can be used to treat idiopathic pulmonary fibrosis (lung scarring from an unknown cause).
Below is a table comparing some of the side effects of Ofev and Esbriet:
| Side effects of Ofev that Esbriet is not known to cause | Side effects of Esbriet that Ofev is not known to cause | Side effects that both Ofev and Esbriet cause |
| • back pain • bleeding* • blood clots* • hair loss | • heartburn • gastroesophageal reflux disease | • diarrhea • abdominal pain • vomiting • nausea • decreased appetite, which may lead to weight loss • headache • fatigue • allergic reaction • liver problems |
* To learn more about this side effect, see the “Serious side effects of Ofev” section above.
If you have questions about the side effects of Ofev or Esbriet, talk with your doctor. They’ll also help determine the best treatment option for you.
Does Ofev cause eye-related side effects?
No. Ofev should not cause eye-related side effects. In clinical trials, eye-related problems, including vision changes, were not reported by people taking the drug.
However, it’s possible to experience jaundice due to liver problems, a side effect of Ofev. This can cause yellowing of the whites of your eyes. If you notice changes in the whites of your eyes during your Ofev treatment, tell your doctor. They can check for liver problems using a liver function test.
In addition, if you notice any eye problems or vision changes during your treatment with Ofev, tell your doctor. They can help determine what may be causing your symptoms and the best way to treat them.
Should I expect to develop a skin rash during Ofev treatment?
It’s possible to develop a skin rash from taking Ofev. However, rash was not a side effect that people taking Ofev reported in clinical trials. Instead, rash was reported as a side effect after Ofev became available for use. However, it’s not known for sure if rash was related to Ofev treatment.
Also, it’s possible to develop a rash as a symptom of an allergic reaction* from Ofev. If you develop a rash while taking this medication, talk with your doctor. They can help determine what may be causing your rash and the best way to treat it. If your rash is related to an allergic reaction, your doctor may have you stop Ofev. And they may recommend a different medication to treat your condition.
* To learn more about allergic reaction, see the “Side effect specifics” section above.
Be sure to talk with your doctor about your health history before you take Ofev. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:
Liver problems. If you have any liver problems, tell your doctor before starting treatment with Ofev. This drug can increase levels of certain liver enzymes,* which can lead to or indicate liver damage. If you already have liver problems, taking Ofev may worsen your condition. In some cases, your doctor may recommend that you take a lower dose of Ofev. However, if you have a more severe liver condition, your doctor may recommend a different treatment option for you.
Heart problems. Tell your doctor if you have any heart conditions before starting treatment with Ofev. This drug may increase the risk of blood clots,* which can cause serious problems such as heart attack or stroke. If you already have heart problems, you may have an increased risk of developing heart attack or stroke while taking Ofev. Your doctor can help determine if Ofev is a safe treatment option for you.
History of blood clots. If you’ve ever had a blood clot, including a heart attack or stroke, tell your doctor before starting Ofev. This drug can increase your risk of blood clots. If you’ve had a blood clot in the past, your risk of having one during Ofev treatment may be higher than someone who has never had one. In this case, your doctor can help determine if Ofev is safe for you to take.
Bleeding problem or family history of bleeding problems. Ofev may increase the risk of bleeding as a side effect.* If you have a bleeding problem such as anemia or hemophilia, taking Ofev may increase your risk of bleeding further. This risk is also higher if you have a family history of bleeding problems. In these cases, your doctor will help determine if Ofev is a safe treatment option for you.
Allergic reaction. If you’ve had an allergic reaction† to Ofev or any of its ingredients, your doctor will likely not prescribe Ofev. Ask your doctor what other medications may be better options for you.
Smoking. Tell your doctor if you smoke before you start treatment with Ofev. Smoking may make Ofev less effective than usual. In addition, smoking can also increase your risk of side effects from the drug. This includes blood clots, which can lead to heart attack or stroke. Smoking can also cause lung damage. And since Ofev is used to treat lung conditions, smoking during treatment may worsen your condition. Due to these risks, your doctor will likely recommend that you avoid smoking during your treatment with Ofev.
Recent surgery in your abdomen. Tell your doctor if you’ve had a recent surgery in your abdomen. Ofev may increase your risk of gastrointestinal perforation.† If you’ve had a recent abdominal surgery, you may have an increased risk of this side effect occurring. In this case, your doctor can help determine if Ofev is a safe treatment option for you.
Kidney problems. Ofev may cause protein in your urine* as a side effect. This can indicate kidney problems. So, if you have existing kidney problems, taking Ofev may worsen your condition. Also, this drug wasn’t studied in people with serious kidney problems. So, it’s not known what effects the drug may have on people with these problems. If you have kidney problems, tell your doctor. They can help determine if it’s safe for you to take Ofev based on your condition.
Diverticular disease. If you have diverticular disease, tell your doctor before taking Ofev. This medication may increase your risk of developing a gastrointestinal perforation. If you have diverticular disease, you may have an increased risk of this side effect. In this case, your doctor can help determine if taking Ofev is right for you.
* To learn more about this side effect, see the “Serious side effects of Ofev” section above.
† For details about this side effect, see the “Side effect specifics” section above.
Alcohol with Ofev
There aren’t any known interactions between alcohol and Ofev. However, it’s possible that drinking alcohol while taking Ofev may increase your risk of side effects from the drug. Both alcohol and Ofev may cause nausea, vomiting, or headache. So, the combination may further increase the risk and severity of these side effects.
In addition, alcohol can increase your risk of more serious side effects of Ofev.* Both alcohol and Ofev can cause liver problems. So, drinking alcohol while taking Ofev may increase this risk further.
If you’d like to drink alcohol while taking Ofev, talk with your doctor to see if it’s safe. They can advise you on how much, if any, is safe.
* To learn more about this side effect, see the “Serious side effects of Ofev” section above.
Pregnancy and breastfeeding while taking Ofev
Below is information about Ofev treatment during pregnancy or while breastfeeding.
Pregnancy
Ofev is not safe to take during pregnancy.
This drug has not been studied in pregnant people. So, it’s unknown what effects the drug may have on a developing fetus. However, based on animal studies and clinical trials of how Ofev works in the body, it’s believed Ofev may cause problems with fetal development.
In animal studies, congenital anomalies (also known as birth defects) and pregnancy loss were reported when pregnant animals were exposed to Ofev. However, animal studies do not always indicate what may happen in humans.
Due to these possible risks, your doctor will recommend that you take a pregnancy test before starting Ofev treatment. Also, people who can become pregnant should use effective birth control while taking Ofev. And they should use it for at least 3 months after stopping treatment.
If you are pregnant or planning to become pregnant, be sure to talk with your doctor before taking Ofev.
Breastfeeding
Ofev is not safe to take while breastfeeding.
There isn’t any information on the safety of Ofev while breastfeeding or if the drug may pass into breast milk. However, in animal studies, Ofev passes into the breast milk of animals exposed to the drug. It’s important to note that animal studies do not always indicate what may happen in humans.
However, due to the possible risks that may occur if a breastfeeding child is exposed to Ofev, your doctor will likely not recommend that you breastfeed during Ofev treatment.
If you are breastfeeding, make sure to talk with your doctor before taking Ofev.
In most cases, side effects that you may experience from Ofev are mild. However, other times, side effects from this drug may be serious.
If you’d like to learn more about Ofev, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.
Besides talking with your doctor, you can do some research on your own. These articles might help:
- More information about Ofev. For details about other aspects of Ofev, refer to this article.
- Dosage. For information about the dosage of Ofev, view this article.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.